← Back to Search

Procedure

BCI-Controlled Robotic Exoskeleton for Stroke

N/A
Waitlist Available
Research Sponsored by Neurolutions, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults age (18-85)
Adults who sustained a CVA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 week completion
Awards & highlights

Study Summary

This trial tests a remote BCI system & robotic exoskeleton to help chronic stroke patients with arm paralysis improve motor function.

Who is the study for?
This trial is for adults aged 18-85 who have had a stroke and now experience weakness or paralysis in one arm. They should not be receiving other upper extremity therapies, have severe cognitive impairments, contractures that prevent device use, certain communication difficulties, or conditions affecting pain sensation.Check my eligibility
What is being tested?
The study compares the effectiveness of a home-based brain-computer interface therapy using the IpsiHand System against standard exercises for improving arm function after stroke. Participants will either use the BCI-controlled robotic hand exoskeleton at home or follow an exercise program.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the exoskeleton device and fatigue due to exercise therapy. There might also be skin irritation where the device attaches to the hand.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 85 years old.
Select...
I have had a stroke.
Select...
I have weakness or paralysis in one arm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 week completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 week completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Upper Extremity Remote Fugl-Meyer
Secondary outcome measures
Gross Grasp Strength
Motor Activity Log

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of Care - Home Exercise Program for Upper ExtremityExperimental Treatment1 Intervention
Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Once randomized, the participant will be assigned to group 2 to begin standard of care treatment at home. Phase 2: After being assigned to Group 2, subjects will serve as the control group in the study. Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks to control for the non-specific motor and sensory effects of BCI training. To help ensure compliance with the at-home portion of the protocol in the control group, participants will receive daily virtual monitoring from the study clinical specialist.
Group II: BCI treatment Group using the IpsiHandExperimental Treatment1 Intervention
Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Subjects will undergo an EEG screening protocol to ensure that a consistent control signal will be present to control the IpsiHand device. After an EEG screening session is complete, the participants screening data will be analyzed to ensure that sufficient cortical signals are present. Randomization for assignment to group 1 or 2 will then occur. Once assigned to group 1, if consistent signals are found, the participant will then continue to Phase 2. Phase 2: Group 1 subjects will be provided with a Neurolutions IpsiHand BCI system, which combines a novel powered exoskeleton with a commercial EEG amplifier and active electrode system. The exoskeleton opens and closes the patient's hand in a three-finger pinch grip. Patients will use the BCI system on a minimum of 5 days per week for 12 weeks. Patients will complete five or more 10-minute runs of the BCI task per day.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineOTHER
1,931 Previous Clinical Trials
2,299,629 Total Patients Enrolled
Neurolutions, Inc.Lead Sponsor
3 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

IpsiHand Device (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05965713 — N/A
Brain-Computer Interface Research Study Groups: Standard of Care - Home Exercise Program for Upper Extremity, BCI treatment Group using the IpsiHand
Brain-Computer Interface Clinical Trial 2023: IpsiHand Device Highlights & Side Effects. Trial Name: NCT05965713 — N/A
IpsiHand Device (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05965713 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study accept volunteers aged 25 or above?

"This study is searching for participants ranging from 18 years of age to 85 years old."

Answered by AI

Would I be eligible to join this clinical trial?

"To become a part of this study, applicants must have suffered from stroke and fall in the age range 18-85. Currently, around 80 participants are being sought out for recruitment."

Answered by AI

Are there any current vacancies for participants in this research study?

"As indicated on clinicaltrials.gov, this medical experiment is not presently seeking participants; however, it was originally posted on October 1st 2023 and the details were last modified on July 25th 2023. Although enrollment has been closed for this study, over one thousand other trials are open to patients at present."

Answered by AI

Who else is applying?

What site did they apply to?
Neurolutions
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I still have paralyse in my upper lumb and want to try this new system.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke
2023. "National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05965713.
~43 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top